The Recall Desk
HighFDA (Devices)·Z-1461-2017·Announced 2017-03-22

Kiscomedica Recalls L-Varlock Cage/Trial Implant Holder Due to Breakage

Kiscomedica S.A. is recalling 13 units of the L-Varlock Cage/Trial Implant Holder because the tip holder broke during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device failure (breakage during use) which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Kiscomedica S.A. is recalling 13 units of the L-Varlock Cage/Trial Implant Holder, Reference HD0060, manufactured by Kisco International in France. The product is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease of the lumbar spine.

The recall was initiated after the firm received a complaint that the tip holder broke during use. The affected units are identified by batch number 15486. The products were distributed worldwide, including in the United States (specifically Missouri) and Switzerland.

Healthcare providers and patients should stop using the affected L-Varlock Cage/Trial Implant Holder units immediately. Users should contact Kiscomedica S.A. for further instructions regarding the recall and potential replacement or repair.

The recalled product

Product
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or
Manufacturer
Kiscomedica S.A.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch number: 15486

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · device failure

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